1. HCV-naive patients in need of heart or lung transplants who received organs from HCV-positive donors and were treated with sofobuvir-velpatasvir demonstrated intact graft function with undetectable viral loads during post-surgical follow up.
2. No treatment-related serious adverse effects were noted in the study population.
Evidence Rating Level: 2 (Good)
Study Rundown: The scarcity of available donor heart and lungs prompts the need for investigators to look for innovative ways to treat patients in need of organ transplantation. Historically, patients with chronic infectious diseases such as hepatitis C (HCV) were not permitted to be donors due to the possible transmission of the virus to a virus-naive recipient during or after the transplantation process. In this current study, Donors of Hepatitis C NAT Positive Thoracic Allografts for Transplantation Evaluation in Non-HCV Recipients (DONATE HCV), investigators studied the use of antiviral agents sofosbuvir-velpatasvir as a way to prevent HCV-naive recipients from developing HCV infections after receiving either heart or lung donations from HCV positive donors. Overall, researchers found that treating patients with this particular antiviral regimen led to undetectable viral loads at 12 weeks post-transplantation, as well as intact graft function at 6 months post-transplantation. While these results are novel, the sample size used was small, indicating that further research is necessary to corroborate these results and evaluate the safety profile of this treatment option.
In-Depth [Phase II Clinical Trial]: This pilot trial analyzed data from 44 patients on the waiting list for a heart or lung transplant from 2017 to 2018; 36 patients received lung transplants and 8 received heart transplants. All patients received a 4-week dose of sofosbuvir (400mg) plus velpatasvir (100 mg) once daily for four weeks starting on the day they received their transplanted organ. The primary outcome of this analysis was to study the combined result of sustained virologic response at 12 weeks after completing the antiviral regimen with intact graft survival at six months after transplantation. Secondary outcomes included safety outcomes including any occurrence of grade 3 or higher adverse events, graft survival at 1 month and 1 year post-transplantation, death rates at 1 month, 6 months and 1 year after transplantation, and evidence of a sustained virologic response 4 weeks and 24 weeks after completing the antiviral regimen. Overall, the primary outcome was met in all 35 patients who had at least 6 months of follow-up data at the time of analysis (100: 95% CI 90 to 100). Of the 9 remaining patients, 5 patients had data available through week 8 of therapy and all showed a sustained virologic response after 4 weeks post completion of the antiviral therapy. Approximately 95% (42 of 44 patents) had detectable HCV viral loads after transplantation, with median initial loads of 1800 IU per millimeter (IQR 800 to 6180). However, all recipients subsequently had an undetectable load by 2 weeks after transplantation. In terms of secondary outcomes, 15 of 16 recipients with data available at 12 months after transplantation had evidence of graft survival at 12 months (94%). All 35 with 6 months of follow up data had a sustained virologic response after 4 weeks of completing the antiviral therapy. In terms of safety outcomes, no irreversible grade 3 or higher adverse events were deemed to be related to the study treatment.
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